Senior PV Safety Scientist (Remote)

Sumitomo Pharma; Dover (DE); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles. You will work with PV, Medical Safety, and cross-functional teams to manage benefit-risk profiles and ensure patient safety.

Responsibilities include signal detection, aggregate reporting, safety governance, and inspection readiness. This is a primarily remote role with some on-site meetings and readiness for domestic/international travel.

Qualifications

• Strong knowledge of pharmacovigilance and risk management across product lifecycle.
• Ability to investigate safety issues and contribute to risk mitigation.
• Understanding of FDA/EMA/GVP/ICH guidelines and safety reporting requirements.
• Experience with signal detection, aggregate reporting, and safety governance.
• Ability to communicate safety information clearly to diverse audiences.

Responsibilities

• Collaborate with PV and cross-functional teams to manage benefit-risk profiles.
• Lead data gathering, analysis, and writing for aggregate safety reports.
• Prepare safety governance materials and participate in SMT meetings.
• Coordinate responses to regulatory inquiries and safety issues.
• Support inspection readiness and process improvements within PV Operations.

Skills

Pharmacovigilance

Signal detection

Regulatory compliance

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in health/life sciences

Master’s degree preferred

Job description

Sumitomo Pharma America (SMPA) is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles. You will work with PV, Medical Safety, and cross-functional teams to manage benefit-risk profiles and ensure patient safety.

Responsibilities include signal detection, aggregate reporting, safety governance, and inspection readiness. This is a primarily remote role with some on-site meetings and readiness for domestic/international travel.